Comparative Biomechanical Behavior and Healing Profile of a Novel Thinned Wall Ultrahigh Molecular Weight Amorphous Poly-l-Lactic Acid Sirolimus-Eluting Bioresorbable Coronary Scaffold.

BACKGROUND: Mechanical strength of bioresorbable scaffolds (BRS) is highly dependent on strut dimensions and polymer features. To date, the successful development of thin-walled BRS has been challenging. We compared the biomechanical behavior and vascular healing profile of a novel thin-walled (115 µm) sirolimus-eluting ultrahigh molecular weight amorphous poly-l-lactic acid-based BRS (APTITUDE, Amaranth Medical [AMA]) to Absorb (bioresorbable vascular scaffold [BVS]) using different experimental models. METHODS AND RESULTS: In vitro biomechanical testing showed no fractures in the AMA-BRS when overexpanded 1.3 mm above nominal dilatation values (≈48%) and lower number of fractures on accelerated cycle testing over time (at 21 K cycles=20.0 [19.5-20.5] in BVS versus 4.0 [3.0-4.3] in AMA-BRS). In the healing response study, 35 AMA-BRS and 23 BVS were implanted in 58 coronary arteries of 23 swine and followed-up to 180 days. Scaffold strut healing was evaluated in vivo using weekly optical coherence tomography analysis. At 14 days, the AMA-BRS demonstrated a higher percentage of embedded struts (71.0% [47.6, 89.1] compared with BVS 40.3% [20.5, 63.2]; P=0.01). At 21 days, uncovered struts were still present in the BVS group (3.8% [2.1, 10.2]). Histopathology revealed lower area stenosis (AMA-BRS, 21.0±6.1% versus BVS 31.0±4.5%; P=0.002) in the AMA-BRS at 28 days. Neointimal thickness and inflammatory scores were comparable between both devices at 180 days. CONCLUSIONS: A new generation thinned wall BRS displayed a more favorable biomechanical behavior and strut healing profile compared with BVS in normal porcine coronary arteries. This novel BRS concept has the potential to improve the clinical outcomes of current generation BRS.

Comparative Characterization of Biomechanical Behavior and Healing Profile of a Novel Ultra-High-Molecular-Weight Amorphous Poly-l-Lactic Acid Sirolimus-Eluting Bioresorbable Coronary Scaffold.

BACKGROUND: Clinically available bioresorbable scaffolds (BRS) rely on polymer crystallinity to achieve mechanical strength resulting in limited overexpansion capabilities and structural integrity when exposed to high-loading conditions. We aimed to evaluate the biomechanical behavior and vascular healing profile of a novel, sirolimus-eluting, high-molecular-weight, amorphous poly-l-lactic acid-based BRS (Amaranth BRS). METHODS AND RESULTS: In vitro biomechanical testing was performed under static and cyclic conditions. A total of 99 devices (65 Amaranth BRS versus 34 Absorb bioresorbable vascular scaffold [BVS]) were implanted in 99 coronary arteries of 37 swine for pharmacokinetics and healing evaluation at various time points. In the Absorb BVS, the number of fractures per scaffold seen on light microscopy was 6.0 (5.0-10.5) when overexpanded 1.0 mm above nominal values (≈34%). No fractures were observed in the Amaranth BRS group at 1.3 mm above nominal values (≈48% overexpansion). The number of fractures was higher in the Absorb BVS on accelerated cycle testing over time (at 24K cycles=5.0 [5.0-9.0] Absorb BVS versus 0.0 [0.0-0.5] Amaranth BRS). Approximately 90% of sirolimus was found to be eluted by 90 days. Optical coherence tomography analysis demonstrated lower percentages of late scaffold recoil in the Amaranth BRS at 3 months (Amaranth BRS=-10±16.1% versus Absorb BVS=10.7±13.2%; P=0.004). Histopathology analysis revealed comparable levels of vascular healing and inflammatory responses between both BRSs up to 6 months. CONCLUSIONS: New-generation high-molecular-weight amorphous poly-l-lactic acid scaffolds have the potential to improve the clinical performance of BRS and provide the ideal platform for the future miniaturization of the technology.

Effect of sensory substitution on suture-manipulation forces for robotic surgical systems.

OBJECTIVES: Direct haptic (force or tactile) feedback is not yet available in commercial robotic surgical systems. Previous work by our group and others suggests that haptic feedback might significantly enhance the execution of surgical tasks requiring fine suture manipulation, specifically those encountered in cardiothoracic surgery. We studied the effects of substituting direct haptic feedback with visual and auditory cues to provide the operating surgeon with a representation of the forces he or she is applying with robotic telemanipulators. METHODS: Using the robotic da Vinci surgical system (Intuitive Surgical, Inc, Sunnyvale, Calif), we compared applied forces during a standardized surgical knot-tying task under 4 different sensory-substitution scenarios: no feedback, auditory feedback, visual feedback, and combined auditory-visual feedback. RESULTS: The forces applied with these sensory-substitution modes more closely approximate suture tensions achieved under ideal haptic conditions (ie, hand ties) than forces applied without such sensory feedback. The consistency of applied forces during robot-assisted suture tying aided by visual feedback or combined auditory-visual feedback sensory substitution is superior to that achieved with hand ties. Robot-assisted ties aided with auditory feedback revealed levels of consistency that were generally equivalent or superior to those attained with hand ties. Visual feedback and auditory feedback improve the consistency of robotically applied forces. CONCLUSIONS: Sensory substitution, in the form of visual feedback, auditory feedback, or both, confers quantifiable advantages in applied force accuracy and consistency during the performance of a simple surgical task.

Effect of sensory substitution on suture manipulation forces for surgical teleoperation.

Bilateral telemanipulation, which applies haptic feedback to the operator, is not yet available in most commercial robot-assisted surgical systems. We have shown in previous work that the lack of haptic (force or tactile) feedback is detrimental in applications requiring fine suture manipulation. In this paper, we study the effect of substituting direct haptic feedback with visual and auditory cues. Using the da Vinci robot from Intuitive Surgical, we observed the difference between applied forces during a knot tying procedure for four different sensory feedback substitution scenarios: no feedback, auditory feedback, visual feedback, and a combination of auditory and visual feedback. Our results indicate that visual feedback, which provides continuous force information, would improve robot-assisted performance during complex surgical tasks such as knot tying with fine sutures. Discrete auditory feedback gives additional useful support to the surgeon.